Download FINAL Feinberg Lecture - Slater - 11-21-2002

Fostering Innovation
in Medicine and Research
Eve E. Slater, M.D., F.A.C.C.
Assistant Secretary for Health
Department of Health and Human Services
2002 Charles C. Leighton, M.D., Memorial Lecture
University of Pennsylvania
October 18, 2002
Thomas Jefferson’s Library
United States Library of Congress
Memory
Reason
Imagination
1900-present
A Century of Innovation
• Increased Life Expectancy
• Increased Cancer Survival Rate
• Decreased Cardiovascular Mortality
• Advent of Vaccines
• Human Genome Project
. . . . . . . . . . . . . . . . . . . . .and so much more
Investment in
Medical Research and Care
more in improved health than
“weReceiving
pay in treatment costs implies that
medical care is a more productive
investment than the average use of our
funds outside the medical sector.
”
Cutler, McClellan, and Newhouse
1998
Federal Funding for
National Institutes of Health (NIH)
• Doubling of NIH budget in 5 years (1998-2003)
to $27 billion in Fiscal Year 2003
• NIH budget in 1960: $182 million
• Clinical research funding: 32% of budget
(Fiscal Year 2001)
PhRMA Member Companies’ R&D Expenditures
and NIH Obligations
PhRMA Domestic R&D
PhRMA R&D Abroad
PhRMA Total R&D
NIH OBLIGATIONS
$30
($ Billions)
$25
$20
$15
$10
$5
$0
1970
1974
1978
1982
1986
1990
1994
1998
Selected Federal Legislative Milestones
• Bayh Dole Act (1980): removed barriers to patent ownership from
federally supported research
$40 billion/260,000 jobs (1999)
• Stevenson Wydler Act (1980): stimulated public-private partnerships
• Orphan Drug Act (1983): encouraged research and development
for drugs for orphan diseases
• National Cooperative Research Act (1984): eased antitrust concerns
• Waxman Hatch Act (1984): protected intellectual property
• Federal Technology Transfer Act (1986): stimulated technology
transfer
• Clinical Research Enhancement Act (2000): encouraged funding for
clinical research
“
These new paradigms will require a
reexamination of the structure of the
U.S. medical research institutions and
government to ensure that they reflect
and accommodate new multidisciplinary
research and development processes.
”
Senator William H. Frist, M.D.
Journal of the American Medical Association, May 2002
Institute of Medicine
Reports on Quality
• Medical Errors:
approximately 45,000-100,000 per year
• Cost:
approximately $17-$29 billion per year
• Hospital Drug Errors:
approximately $2 billion per year
“
The Administration supports your
(U.S. House of Representatives) efforts to
pass ... and enact legislation to remove the
liability barriers to improving quality and
safety of health care.
”
Secretary Tommy G. Thompson
September 10, 2002
Drug Development Costs
(source: Tufts CSDD)
2002 cost = $802 million
• 19% reduction in all phases length =
$100 million saved
• 21.5% to 25.5% increase in clinical success rate =
$100 million saved
• If phase III studies decrease by 1 year =
$71.4 million saved
• If 33% decrease in development and regulatory review
time = $1.7 million saved
Innovation and Cost
Memory:
Federal Funding and Key Legislation
Reason:
Translational Research
Prioritization and Dialogue
Imagination:
Infrastructure for Quality
Availability and Access